Pessary device

ABSTRACT

A non-expandable pessary device, the pessary device having a top, a base, a length, a longitudinal axis, a maximum diameter, and a minimum diameter that is less than the maximum diameter. The pessary device has a pressure region adapted to extend between an anterior vaginal wall and a posterior vaginal wall of a user to provide pressure on the user&#39;s urethra through the vaginal wall. The pressure region includes the maximum diameter, and the maximum diameter is less than 25 mm.

FIELD OF INVENTION

This application relates to pessary devices for relief of femaleincontinence. More particularly, the present invention relates topessary devices having improved configurations.

BACKGROUND OF THE INVENTION

Urinary incontinence, in which the ordinary bodily muscle functions failto prevent unintended leakage of urine, is a common malady among women,particularly older women. It is estimated that up to 50% of womenoccasionally leak urine involuntarily, and that approximately 25% ofwomen will seek medical advice at some point in order to deal with theproblem. Stress incontinence, the most common type of urinaryincontinence, refers to the involuntary loss of urine resulting fromabdominal pressure rise, occurring during exercise, coughing, sneezing,laughing, etc. When stress incontinence occurs, it is usually the resultof the abnormal descent of the urethra and bladder neck below the levelof the pelvic floor. Many women wear sanitary napkins or diapers inorder to deal with incontinence, and some women resort to surgicalprocedures.

Pessary devices are known to help relieve involuntary urination in afemale. Such devices are designed for arrangement in the vagina forcompressive action on and support of the bladder. Typical pessarydevices are large in diameter during use, and may elastically expand,inflate, or unfold to provide compressive action within the vagina. Suchpessary devices can be uncomfortable for a user and/or can require theuser to activate or operate the device prior to or upon insertion of thepessary device into the vagina. This can result in an undesirable usageexperience.

As such, there remains a need for a pessary device with improved comfortduring use. There also remains a need for a pessary device that is smallin size yet effective. In addition, there remains a need for adisposable pessary device that can be used daily.

SUMMARY OF THE INVENTION

A non-expandable pessary device is provided. The pessary device has atop, a base, a length, a longitudinal axis, a maximum diameter, and aminimum diameter that is less than the maximum diameter. The pessarydevice includes a pressure region adapted to extend between an anteriorvaginal wall and a posterior vaginal wall of a user to provide pressureon the user's urethra through the vaginal wall. The pressure regionincludes the maximum diameter, wherein the maximum diameter is less thanabout 25 mm.

Further provided is a non-expandable pessary device having a top, abase, a length, a longitudinal axis, a maximum diameter, a seconddiameter, and a minimum diameter that is less than the maximum diameterand the second diameter. The pessary device has a first pressure regionadapted to extend between an anterior vaginal wall and a posteriorvaginal wall of a user to provide pressure on the user's urethra throughthe vaginal wall. The first pressure region includes the maximumdiameter, wherein the maximum diameter is less than about 25 mm. Thepessary device also has a second pressure region that includes thesecond diameter, the second pressure region being provided apart fromthe first pressure region.

Also provided is a non-expandable pessary device having a top, a base, alength, a longitudinal axis, a maximum diameter, and a minimum diameterthat is less than the maximum diameter. The pessary device has apressure region adapted to extend between an anterior vaginal wall and aposterior vaginal wall of a user to provide pressure on the user'surethra through the vaginal wall. The pressure region includes themaximum diameter. The pessary device also has a flexile region includingthe minimum diameter, wherein the pressure region is more resistant thanthe flexile region.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter of the present invention, itis believed that the invention can be more readily understood from thefollowing description taken in connection with the accompanyingdrawings, in which:

FIG. 1A is a side view of a pessary device.

FIG. 1B is a perspective view of the pessary device of FIG. 1A.

FIG. 2A is a side view of a pessary device.

FIG. 2B is a perspective view of the pessary device of FIG. 2B.

FIG. 3 is a cross-section view of a pessary device.

FIG. 4 is a cross-section view of a pessary device.

FIG. 5 is a cross-section view of a pessary device.

FIG. 6 is a perspective view of a pessary device.

FIG. 7 is a side view of a pessary device.

FIG. 8 is a side view of a pessary applicator, housing the pessary ofFIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to pessary devices that are insertedinto the female vagina to help control involuntary urinary incontinence.The pessary devices are non-expandable, small in size, and can provideimproved comfort during use. The pessary devices can include a pressureregion adapted to extend between an anterior vaginal wall and aposterior vaginal wall of a user to provide pressure on the user'surethra through the vaginal wall. The pressure region includes themaximum diameter of the pessary, wherein the maximum diameter is lessthan 25 mm. The pessary device also can include a second pressure regionprovided apart from the first pressure region. In addition, the pessarydevice also can include a flexile region that can include the minimumdiameter of the pessary device. The flexile region is more flexible thanthe pressure region, and the pressure region is more resistant than theflexile region under high stress conditions, such as, for example, whenthe user coughs. This can provide for a small and comfortable, yeteffective, pessary device.

A woman with stress incontinence can experience involuntary loss ofurine with increases in abdominal pressure, such as, for example, duringexercise, coughing, sneezing, laughing, or valsalva maneuvers. This lossof urine is thought to occur because the muscles and connective tissuethat support the bladder and/or urethra are weakened or injured andcannot fully support the bladder and/or urethra during stress incidents,leading to leaks. Physical changes due to childbirth, menopause, injury,surgery, and pelvic organ prolapse often can cause stress incontinence.Surprisingly, the pessary devices described herein can provideresistance sufficient to prevent leakage during increases in abdominalpressure while remaining flexible and small enough to provide comfortduring wear.

As used herein, “applicator” refers to a device or implement thatfacilitates the insertion of the pessary device into an external orificeof a mammal. Exemplary applicators include telescoping, tube andplunger, and compact applicators.

The term “joined” or “attached” as used herein, encompassesconfigurations in which a first element is directly secured to a secondelement by affixing the first element directly to the second element,configurations in which the first element is indirectly secured to thesecond element by affixing the first element to intermediate member(s)which in turn are affixed to the second element, and configurations inwhich first element is integral with second element, i.e., first elementis essentially part of the second element.

As used herein, the term “non-expandable” refers to devices that do notexpand prior to or during use, such as, for example, devices that do notincrease in size or volume prior to or during use. For example,non-expandable devices have a diameter and/or volume that does notincrease. In contrast, “expandable” as used herein, refers to devicesthat do increase in size or volume prior to or during use, such as, forexample, devices that increase in diameter and/or length, absorb fluidinto a fibrous or absorbent gelling material structure, or otherwisechange from a first size or volume to a second size or volume, such as,for example, by inflation, absorption, mechanically, or by other means.Insubstantial changes to a non-expandable device as a result of anythermal expansion that could occur at body temperatures are notconsidered “expansion.”

A “pessary device” or more particularly an “incontinence pessary device”as used herein refers to devices specifically designed, configured,and/or adapted for placement into a vagina in order to reduce theoccurrence and/or severity of female urinary incontinence. A “pessarydevice” can include any type of substantially non-absorbent structurefor the purpose of reducing urine leakage and/or supporting a prolapseduterus and/or bladder. A pessary device does not include a menstrualtampon.

As used herein, the term “vaginal canal” refers to the internalgenitalia of the human female in the pudendal region of the body. Theterms “vaginal canal” or “within the vagina” as used herein are intendedto refer to the space located between the introitus of the vagina(sometimes referred to as the sphincter of the vagina) and the cervix.

An exemplary pessary device 10 is shown in FIGS. 1A and 1B. The pessarydevice 10 includes an upper portion 20, a lower portion 30, a middleportion 40, a pressure region 50 of the upper portion 20, a pressureregion 60 of the lower portion 30, a maximum diameter D₁, a minimumdiameter D₂, a slope 80 extending from the upper portion 20 to themiddle portion 40, a slope 90 from the middle portion 40 to the lowerportion 30, a longitudinal axis (L) and a transverse axis (T). As shownin FIGS. 1A and 1B, the pessary device 10 can have a top 100 thatincludes a convex portion 110, a base 120 that includes a convex portion130, and sides 140 that include concave portions 150. The pessary devicecan be symmetric about the longitudinal axis, including for example,wherein the base is circular and symmetric about the longitudinal axis.The pessary device can include a third diameter D₃ that is greater thanminimum diameter D₂, and convex portion 110 can be aligned with maximumdiameter D₁ to provide pressure region 50, and convex portion 130 can bealigned with maximum diameter D₁ to provide pressure region 60. Inaddition, concave portion 150 can be aligned with minimum diameter D₂ toform flexile region 160.

FIGS. 2A and 2B show a pessary device 10. The pessary device 10 includesan upper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum diameter D₁, a minimum diameter D₂, a slope 80extending from the upper portion 20 to the middle portion 40, a slope 90from the middle portion 40 to the lower portion 30, a longitudinal axis(L) and a transverse axis (T). As shown in FIGS. 2A and 2B, the pessarydevice 10 can have a top 100 that includes a convex portion 110, a base120 that includes a convex portion 130, and sides 140 that includeconcave portions 150. The pessary device shown in FIGS. 2A and 2B has anupper slope 80 that is greater than the upper slope 80 of the pessarydevice shown in FIGS. 1A and 1B. As shown in FIGS. 2A and 2B, pessarydevice 10 can include flexile region 160. In addition, the pessarydevice shown in FIGS. 2A and 2B has a lower slope 90 that is greaterthan the lower slope 90 of the pessary device shown in FIGS. 2A and 2B.

FIG. 3 shows a pessary device 10 take along line 3-3 of FIG. 1. Thepessary device 10 includes an upper portion 20, a lower portion 30, amiddle portion 40, a pressure region 50 of the upper portion 20, apressure region 60 of the lower portion 30, a maximum diameter D₁, aminimum diameter D₂, a slope 80 extending from the upper portion 20 tothe middle portion 40, a slope 90 from the middle portion 40 to thelower portion 30, and a longitudinal axis (L). As shown in FIG. 3, thepessary device 10 can have a top 100 that includes a convex portion 110,a base 120 that includes a convex portion 130, and sides 140 thatinclude concave portions 150. As shown in FIG. 3, the pessary device 10can have outer wall 250 and an interior 200 defined by inner walls 240that is hollow in region 220. The hollow region 220 can be provided atone or both ends. In addition, the pessary device 10 can have a portionof the interior 200 that is solid.

FIG. 4 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum diameter D₁, a minimum diameter D₂, a slope 80extending from the upper portion 20 to the middle portion 40, a slope 90from the middle portion 40 to the lower portion 30, and a longitudinalaxis (L). As shown in FIG. 4, the pessary device 10 can have a top 100that includes a convex portion 110, a base 120 that includes a convexportion 130, and sides 140 that include concave portions 150. As shownin FIG. 4, the pessary device 10 can have an interior 200 that ishollow. The pessary device has inner walls 240 that define interior 200and hollow region 220. In addition, the inner walls 240 can have thesame or a similar profile as the outer walls 250.

FIG. 5 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum diameter D₁, a minimum diameter D₂, a slope 80extending from the upper portion 20 to the middle portion 40, a slope 90from the middle portion 40 to the lower portion 30, and a longitudinalaxis (L). As shown in FIG. 5, the pessary device 10 can have a top 100that includes a convex portion 110, a base 120 that includes a convexportion 130, and sides 140 that include concave portions 150. As shownin FIG. 5, the pessary device 10 has an interior 200 that is hollow. Thepessary device has inner walls 240 that define interior 200 and hollowregion 220. The hollow region 220 can have a first profile defined byinner walls 240 and a different profile defined by outer walls 250, suchas, for example, where the hollow region 220 is in the form of a tube.

FIG. 6 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a slope 80 extending from the upper portion 20 to the middleportion 40, a slope 90 from the middle portion 40 to the lower portion30, and a longitudinal axis (L). As shown in FIG. 6, the pessary device10 can have a top 100 that includes a convex portion 110, a base 120that includes a convex portion 130, and sides 140 that include concaveportions 150. The pessary device can also have a flexile region 160. Thepessary device 10 can have an interior 200 that is hollow. In addition,as shown in FIG. 6, the pessary device 10 can have an opening on one ormore of top 100 and/or on base 120.

The pessary device 10 can include an overwrap 300 and/or a withdrawalmember 310, such as, for example, as shown in FIG. 7. In addition, FIG.7 shows that withdrawal member 310 can be attached to overwrap 300.

The pessary device can be inserted in any suitable manner, such as, forexample, using an applicator. FIG. 8 shows an applicator 410 thatincludes an insertion member 420 and a plunger 440. The insertion member420 has an insertion end 421 and a withdrawal end 422 opposite theinsertion end 421. The insertion member 420 also can include a barrelregion 450 adapted to contain a pessary device, and a grip region 430that can be an indentation region 424 provided opposite the insertionend 421, such as, e.g., proximal to the withdrawal end 422. The gripregion 430 can include one or more grip elements 423.

Generally, the pessary device does not change in size during the usageexperience, that is, the pessary device is the same size and diameterprior to insertion by the user as well as during use and removal. Forexample, the pessary device is not expandable or inflatable from itsoriginal size and the pessary device is not compressed for insertioninto the user's body, nor is the pessary device compressed forwithdrawal from the user's body. A portion or region of the pessarydevice can flex or be deformed, such as, for example, in the regionhaving the minimum diameter, but the pessary device does not expand andreturns to the original configuration after deformation. As such, thepessary device does not include any mechanical or other means thatrequires the user to change the size or shape of the pessary deviceduring use, such as, for example, before or after insertion or prior towithdrawal. This provides for a pessary device that has a size uponwithdrawal that is the same as the size during use, which can providefor improved comfort during use and withdrawal.

The pessary device can have a pressure region that has the maximumdiameter of the pessary, such as, for example, at the base or at thetop, that extends between the anterior vaginal wall and the posteriorvaginal wall of a consumer to provide pressure on the urethra throughthe vaginal wall. In addition, the pessary device can have a secondpressure region having an increased diameter as compared to the minimumdiameter that can provide pressure on the urethra through the vaginalwall at a point apart from the first pressure region. The first pressureregion and the second pressure region can be separated by any suitabledistance, such as, for example, by at least about 5 mm, at least about10 mm, at least about 15 mm, at least about 20 mm, at least about 25 mm,at least about 30 mm, at least about 35 mm, at least about 40 mm, atleast about 45 mm, at least about 50 mm, or any other suitable distance.

The pessary device can have any suitable number of pressure regions,including for example, two pressure regions, such as, for example, fouror fewer pressure regions, three or fewer pressure regions, two or fewerpressure regions, one pressure region, or any other suitable number ofpressure regions.

The pressure region or regions can be any suitable shape, such as, forexample, a convex shape that provides pressure to the vaginal wall,including, for example, a lobe or other protuberance. The pressureregion or regions can have a substantially circular cross-section. Thepessary device also can include a minimum diameter region that is aflexile region that can provide flexibility to the pessary device, suchas, for example, by allowing bending or movement at the flexile region.The flexile region can be any suitable shape, such as, for example,concave, indented, or the like, and can have any suitable cross-section,such as, for example, a substantially circular cross-section. In certainembodiments, the pessary device includes a flexile region providedbetween two pressure regions.

The pessary device can provide resistance to force when placed inside awoman's vagina. For example, when the pessary device is inserted intothe vagina, increases in abdominal pressure can act as a force on thepessary device through the vaginal wall. When the pessary device isdisposed in the vagina lengthwise, that is, with the top of the pessarydevice positioned toward the cervix, the bottom of the pessary devicepositioned toward the introitus, and the length of the pessary devicegenerally aligned with the length of the vagina, increases in abdominalpressure can act on the side of the pessary device, perpendicular to thelength of the pessary device. Of course, increases in abdominal pressurecan act on other regions of the pessary device, in addition oralternatively to acting on the side of the pessary device, including forexample, when the pessary device is inserted into the vagina in anorientation other than lengthwise.

Despite its small size, the pessary device can provide a resistance toforce of greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi under about 2 newtons offorce. For example, in certain embodiments, the pessary device canprovide a resistance to force of greater than about 20 psi under about 2newtons of force and greater than about 25 psi under about 3 newtons offorce. The pessary device also can resist compression under pressure.For example, the pessary device can compress less than about 20% underabout 2 newtons of force, less than about 15% under about 2 newtons offorce, less than about 14% under about 2 newtons of force, less thanabout 13% under about 2 newtons of force, less than about 12% underabout 2 newtons of force, less than about 11% under about 2 newtons offorce, less than about 10% under about 2 newtons of force, less thanabout 9% under about 2 newtons of force, less than about 8% under about2 newtons of force, less than about 7% under about 2 newtons of force,less than about 6% under about 2 newtons of force, less than about 5%under about 2 newtons of force, less than about 4% under about 2 newtonsof force, less than about 3% under about 2 newtons of force, less thanabout 2% under about 2 newtons of force, or less than about 1% underabout 2 newtons of force. For example, the pessary device can compressless than about 20% under about 2 newtons of force, less than about 15%under about 2 newtons of force, less than about 14% under about 2newtons of force, less than about 13% under about 2 newtons of force,less than about 12% under about 2 newtons of force, less than about 11%under about 2 newtons of force, less than about 10% under about 2newtons of force, less than about 9% under about 2 newtons of force,less than about 8% under about 2 newtons of force, less than about 7%under about 2 newtons of force, less than about 6% under about 2 newtonsof force, less than about 5% under about 2 newtons of force, less thanabout 4% under about 2 newtons of force, less than about 3% under about2 newtons of force, less than about 2% under about 2 newtons of force,or less than about 1% under about 2 newtons of force.

The pessary devices can provide a varied resistance to force along thelongitudinal axis of the pessary device. For example, the pessary devicecan provide a resistance to force that is greater at the maximumdiameter regions and smaller at the minimum diameter regions. Inaddition, the pessary device can compress differently along thelongitudinal axis at different regions. For example, when force isapplied to the side of the pessary, the minimum diameter region cancompress at least about 5% more than the maximum diameter region underthe same amount of pressure (for example, under about 200 g/m2 offorce), at least about 10% more than the maximum diameter region underthe same amount of pressure, at least about 15% more than the maximumdiameter region under the same amount of pressure, at least about 20%more than the maximum diameter region under the same amount of pressure,or at least 25% more than the maximum diameter region under the sameamount of pressure. Any suitable amount of force can be applied, suchas, for example, from about 200 g/m2 of force to about 1500 g/m2 offorce, from about 200 g/m2 of force to about 1400 g/m2 of force, fromabout 300 g/m2 of force to about 1200 g/m2 of force, or from about 400g/m2 of force to about 800 g/m2 of force.

The amount of resistance to force and the amount of compression underforce provided by the pessary device as a whole or provided by thedifferent regions of the pessary device can be measured in any suitablemanner. For example, one suitable method employs a Universal ConstantRate Elongation/Tensile Tester with computer interface (MTS, EdenPrairie, Minn.). The method measures the force required to compress thepessary device resting on its side at 0.8 mm at a rate of 20 mm per min.For this method, the load probe tip is 5 mm in diameter and the tip issemi-spherical in shape. In addition, the resting fixture is acylindrical steel plate 152 mm in diameter and 13 mm thick. The pessarydevice is placed on the steel table and the crosshead moves at 20 mm/minWhen a force of 2 grams is exhibited on the pessary device, thecrosshead automatically zeroes out and moves an additional 0.8 mm. Theprobe cycles back, and data is acquired at a rate of 100 Hz. This methodmeasures the peak force in grams versus the amount of compression in mmFor pessary devices having varying diameters or widths, such as, forexample, pessary devices having a maximum diameter or width and aminimum diameter or width, resistance to force at the different regionscan be measured using this method. For example, for a pessary device asshown in FIGS. 1A and 1B, resistance to force at the maximum diameterregions D1 and D3 can be measured using a steel plate that is larger insize than the pessary device as the resting fixture. Resistance to forceat the minimum diameter region D2 can be measured using a single rodthat contacts the minimum diameter region but not the maximum diameterregions.

Generally, the pressure region can be resistant such that the pressureregion can provide pressure to the vaginal wall. The pressure regionprovides resistance under high stress pressures typical of the humanvagina, such as, for example, by providing a maximum pressure to theurethra through the vaginal wall greater than about 5 psi, such as, forexample, greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi. In addition, thepressure region can provide a maximum urethral closure of greater thanabout1.0 mm, such as, for example, greater than about 1.1 mm, greaterthan about 1.2 mm, greater than about 1.3 mm, greater than about 1.4 mm,such as, for example, greater than about 1.5 mm, greater than about 1.6mm, greater than about 1.7 mm, greater than about 1.8 mm, or greaterthan about 1.9 mm In addition, or alternatively, the pressure region cancompress less than about 1 mm when measured under 0.5 psi when the forceis applied from one side of the pressure region to the opposite side ofthe pressure region at the region of maximum diameter in the directionperpendicular to the longitudinal axis. Maximum pressure to the urethraand maximum urethral closure can be measured using any suitable method,such as, for example, by using the computational model described in U.S.Patent Appln. No. 2007/0027667. For example, a computation modelsimulating the human internal pelvic environment can be used. In certainembodiments, thirteen nodes on the urethra in the simulation that areboth on the back wall toward the vagina and in the middle of the body onthe sagittal plane can be chosen. The points should be spread even alongthe length of the urethra with the first point at the bottom edge of theurethra and the last point at the bladder neck. Node vs. time vs. VonMises stress should be obtained using a suitable software program, suchas, for example, LS-Prepost, for all chosen nodes. The data columns arethen matched to determine the y position vs. time vs. Von Mises stress.Generally, only the data that is at the simulation end point should beselected and y-position vs. Von Mises is then plotted.

The flexile region, on the other hand, is more flexible than andprovides less resistance than the pressure region. Addition of theflexile region can allow the pessary device to flex in the longitudinaldirection as well at the lateral direction. For example, the pessarydevice can compress more than about 1 cm when measured under 0.5 psiwhen the force is applied from the top to the base along thelongitudinal axis. In addition, or alternatively, the flexile region canprovide a bending region that facilitates the pessary device bendingfrom side to side.

The pessary device can be a unitary construction. For example, thepessary device can include a continuous outer shell that defines theentire exterior surface of the pessary device. The outer shell can besmooth or textured. The outer shell may be permeable to fluid, such as,for example, by the inclusion of holes, pores, or other suitableopenings. Alternatively, the outer shell can be impermeable to fluidsuch that fluid cannot enter the device. In addition, the pessary devicecan include an opening in the top and/or base. In certain embodiments,the pessary device can include an opening in the top and/or base and theouter shell is not permeable to fluid such that fluid cannot enter thedevice except through the opening in the top and/or base.

Suitable pessary devices can be solid or can have a hollow interior. Forhollow devices, the pessary device can have an outer periphery defininga total area of the device and an inner periphery defining an open areaof the device. The open area can be any suitable size, such as, forexample, between about 5% to about 95% of the total area, such as, forexample, from about 10% to about 90% of the total area, from about 15%to about 85% of the total area, or from about 20% to about 80% of thetotal area. In addition, the pessary device also can have a wallthickness that is suitable to maintain the pessary configuration. Thewall thickness can be greater than about 1 mm, such as for example,about 2 mm, about 3 mm, about 4 mm, about 5 mm, or greater. The wallthickness can be constant or varied along the length of the pessarydevice and/or around the circumference of the pessary device.

The pessary device can have any suitable shape having a varied diameteralong the longitudinal axis, such as, for example, a shape having avaried diameter that is symmetrical with respect to the longitudinalaxis, such as, for example, a teardrop, an apple, a pear, an hourglass,a waisted cylinder, a figure-8 shape, a peanut shape, a heart-shape, alight bulb shape, a bottle shape, a vase shape, or any other suitableshape. In addition, the shape can have a varied diameter and can besymmetrical with respect to both the longitudinal and lateral axis, suchas, for example, an hourglass, a waisted cylinder, a figure-8 shape, apeanut shape, or any other suitable shape. Alternatively, the pessarydevice can have an asymmetrical shape, such as, for example, a B-shapeor a P-shape. The pessary device can be symmetrical at one region andasymmetrical at another region, such as, for example, where the pessarydevice has a symmetrical pressure region and an asymmetrical flexileregion. Generally, the pessary device can have a varying diameter thatcan provide varying pressure along the user's urethra. For example, thepessary device can have a convex portion that can correspond to thepressure region. In addition, the pessary device can have a minimumdiameter region that can be a concave region. The concave region cancorrespond to the flexile region.

The pessary device can be hourglass shaped. For example, as shown inFIGS. 1-2, the pessary device can have upper and lower portions joinedtogether by a waistline portion, with the upper and lower portionshaving diameters that are both greater than a diameter of the waistlineportion such that the pessary device has a generally hourglassconfiguration. In this configuration, the upper portion of the pessarydevice can have a top and the lower portion of the pessary device canhave a base, and the pessary device can have sloping upper and lowerwall sections joining the top and the base with the waistline portion.In addition, the waistline portion can include the minimum diameter ofthe pessary device. The upper and lower portions can have generallycoequal maximum diameters, or the upper and lower portions can havedifferent maximum diameters, such as, for example, where the upperportion has a maximum diameter greater than the lower portion or wherethe lower portion has a maximum diameter greater than the upper portion.

Generally, the pessary device includes at least one maximum diameter andat least one minimum diameter, where the minimum diameter is smallerthan the maximum diameter. The pessary device can include a firstportion having a maximum diameter, a second portion having a maximumdiameter, and a third portion that has a minimum diameter. The maximumdiameter of the first portion and the maximum diameter of the secondportion can be separated by a distance that is greater than about 10% ofthe length of the pessary device, such as, for example, by a distancegreater than about 5 mm, greater than about 10 mm, greater than about 15mm, greater than about 20 mm, greater than about 25 mm, greater thanabout 30 mm, greater than about 35 mm, greater than about 40 mm, greaterthan about 45 mm, or more. In certain embodiments, the pessary deviceprovides pressure at mid-urethra, the bladder neck, or both. Inaddition, in certain embodiments, the pessary device provides higherpressure at the mid-urethra, the bladder neck, or both and provideslower pressure at the area between the mid-urethra and the bladder neck.For example, the pressure region can provide pressure at levels about25% higher than the pressure provided by the flexile region, such as,for example, at levels about 30% higher, about 35% higher, about 40%higher, about 45% higher, about 50% higher, about 55% higher, about 60%higher, or more.

The pessary device can have a slope from the maximum diameter to theminimum diameter. Any suitable slope can be used, including for example,about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, about 1.5 mm,about 2 mm, about 2 5 mm, about 3 mm, about 4 mm, about 5 mm, about 6mm, about 7 mm, about 8 mm, or more, such as, for example, a slope fromabout 0.25 mm to about 5 mm, or a slope from about 0 5 mm to about 4 mm,or any other suitable range.

Suitable pessary devices are typically smaller in size than conventionalpessary devices. For example, the pessary devices have a maximumdiameter, a length, and/or a volume that is smaller or less than that ofconventional pessary devices.

The pessary devices can have any suitable maximum diameter, such as, forexample, a maximum diameter of less than 35 mm, such as, for example,less than 34 mm, less than 33 mm, less than 32 mm, less than 31 mm, lessthan 30 mm, less than 29 mm, less than 28 mm, less than 27 mm, less than26 mm, less than 25 mm, less than 24 mm, less than 23 mm, less than 22mm, less than 21 mm, less than 20 mm, less than 19 mm, less than 18 mm,less than 17 mm, less than 16 mm, less than 15 mm, less than 14 mm, lessthan 13 mm, less than 12 mm, less than 11 mm, or less than 10 mm,including, for example, a maximum diameter of from about 10 mm to about35 mm, from about 10 mm to about 25 mm, from about 13 mm to about 25 mm,or from about 15 mm to about 22 mm. The maximum diameter or width istypically measured at the widest portion of the pessary devicesubstantially perpendicular to the longitudinal axis.

The pessary devices can have any suitable minimum diameter that issmaller than the maximum diameter, including, for example, a minimumdiameter from about 40% to about 95% of the maximum diameter, from about40% to about 90% of the maximum diameter, from about 40% to about 85% ofthe maximum diameter, from about 40% to about 80% of the maximumdiameter, from about 45% to about 75% of the maximum diameter, or fromabout 50% to about 70% of the maximum diameter, such as, for example,about 45% of the maximum diameter, about 50% of the maximum diameter,about 55% of the maximum diameter, about 60% of the maximum diameter,about 65% of the maximum diameter, or about 70% of the maximum diameter.

The pessary devices can have a minimum diameter from about 4 mm to about28 mm, about 5 mm to about 20 mm, about 8 mm to about 20 mm, from about8 mm to about 18 mm, or from about 8 mm to about 15 mm, such as, forexample, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10mm, about 10.5 mm, about 11 mm, about 11 5 mm, about 12 mm, about 12.5mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, about 15 mm,about 15.5 mm, about 16 mm, about 16.5 mm, about 17 mm, about 17.5 mm,about 18 mm, about 18.5 mm, about 19 mm, about 19.5 mm, or about 20 mm,or any other suitable minimum diameter. The minimum diameter or width istypically measured at the narrowest portion of the pessary devicesubstantially perpendicular to the longitudinal axis.

The maximum diameter and the minimum diameter can be separated by anysuitable distance, such as, for example, by about 5 mm, about 10 mm,about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about40 mm, about 45 mm, about 50 mm, or any other suitable distance.

The pessary devices can have any suitable length, such as, for example,a length from about 35 mm to about 60 mm, about 40 mm to about 55 mm, orabout 40 mm to about 50 mm, such as, for example, a length about 35 mm,about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm,about 47 mm, about 48 mm, about 49 mm, or about 50 mm. The length istypically measured substantially parallel to the longitudinal axis ofthe pessary device.

Generally, the pessary device can have a weight of less than about 10grams, less than about 9 grams, less than about 8 grams, less than about7 grams, less than about 6 grams, less than about 5 grams, less thanabout 4 grams, less than about 3 grams, less than about 2 grams, orabout 1 gram, including for example, a weight of from about 1 gram toabout 7 grams, or from about 2 grams to about 6 grams, or from about 3grams to about 5 grams.

Pessary devices can be fabricated using any suitable materials andmethods. For example, pessaries can be formed from polymeric materials,such as, for example, polycarbonate, polyester, polyethylene,polyacrylamide, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, nylon, silicone, or mixtures or blends thereof, ormetallic materials. In certain embodiments, the pessary devices are notformed from absorbent material such as, for example, fibrous material orabsorbent foam.

Pessary devices can be formed in any suitable manner, such as, forexample, using injection molding or other suitable methods of formingthe pessary device.

The pessary device can be covered by an overwrap. The overwrap can benon-absorbent or absorbent and can include any suitable material, suchas, for example, a fibrous nonwoven material comprising natural,synthetic, or a blend of natural and synthetic fibers. Suitablesynthetic fibers can include, e.g., fibers such as polyester,polyolefin, nylon, polypropylene, polyethylene, polyacrylic, celluloseacetate, polyhydroxyalkanoates, aliphatic ester polycondensates,bicomponent fibers and/or mixtures thereof. Natural fibers can include,e.g., rayon and those commonly known to be non-synthetic and of naturalorigin such as cotton. The fibers can have any suitable cross-sectionalshape, such as, e.g., round, tri-lobal, multi-lobal, delta, hollow,ribbon-shaped, and/or any other suitable shape, or mixtures thereof.Fibers with any suitable diameter can be used, such as, e.g., from about0.5 to about 50 microns, such as, e.g., from about 1 to about 30microns, such as, e.g., from about 10 to about 25 microns. Fiberdiameter can be determined using any suitable means; however, fornon-round fibers, diameter can typically be determined by reference tothe diameter of a fiber with the same cross-sectional area as thenon-round fiber.

The overwrap can be made by any number of suitable techniques and canhave any suitable basis weight. Suitable techniques include, forexample, carding, meltblowing, spunbonding, spunlacing, air laying, andthe like. For example, the overwrap can be formed using bonding methods,such as, e.g., thermal, ultrasonic, resin, through-air bonding,hydroentangling, and/or needling. The basis weight of the overwrap canbe any suitable weight, such as, e.g., from about 10 to about 60 gramsper square meter (gsm), such as, e.g., from about 15 to about 30 gsm. Inaddition, the overwrap can be hydrophilic or hydrophobic.

The overwrap can be joined to the pessary device by any variety ofmeans. The overwrap can be joined to itself or to the pessary device.For example, one portion of overwrap can be joined to an opposed portionof the overwrap or to the pessary device using any suitable adhesive orheat pressure bonding means. Such adhesive can extend continuously alongthe length of attachment or it can be applied in a non-continuousfashion at discrete intervals. Heat bonding includes thermally bonding,fusion bonding, or any other suitable means for joining such materials.

The pessary device can include a withdrawal member that can comprise anysuitable material, including for example, cotton, cellulose, rayon,polyolefins such as, for example, polyethylene or polypropylene, nylon,silk, polytetrafluoroethylene, wax, or any other suitable materials.

The withdrawal member can be formed by any suitable formation method andin any suitable configuration, such as, e.g., one or more cords,strings, finger covers, ribbons, an extension of a material of thedevice, or combinations thereof.

The pessary device can be inserted using an applicator that can includean insertion member and a plunger. The insertion member can have aninsertion end and a withdrawal end opposite the insertion end. Theinsertion member also can include a barrel region adapted to contain thepessary device, and a grip region that can, in certain embodiments, bean indentation region provided opposite the insertion end, such as,e.g., proximal to the withdrawal end.

The insertion member and/or plunger can be constructed from any suitablematerial. Suitable materials include, for example, paper, paperboard,cardboard, cellulose, such as, e.g., molded cellulose, or anycombinations thereof, polyethylene, polypropylene, polybutylene,polystyrene, polyvinylchloride, polyacrylate, polymethacrylate,polyacrylonitrile, polyacrylamide, polyamide, nylon, polyimide,polyester, polycarbonate, polylactic acid, poly hydroxyalkanoate,ethylene vinyl acetate, polyurethane, silicone, derivatives thereof,copolymers thereof, mixtures thereof, or any suitable smooth plasticmaterial. Examples of suitable materials are disclosed in, e.g., U.S.Pat. Nos. 5,346,468 and 5,558,631. Additives can be included in thematerial to alter or enhance certain material properties. Suitableadditives include, for example, mold release agents, slip agents,surface energy modifiers, pearlescent agents, and/or any other suitableadditives. The insertion member also or alternatively can be coated witha substance to give it a high slip characteristic, such as, e.g., withwax, polyethylene, a combination of wax and polyethylene, cellophane,clay, mica, and other lubricants that can facilitate comfortableinsertion. Alternatively, or in addition, the insertion member caninclude a textured surface. Texture can be provided in any suitablemanner, such as, e.g., by designing texture into or adding texture tothe insertion member.

The insertion member can include a grip region, such as, for example, anindentation region. The grip region can have a plurality ofthree-dimensional surface elements, such as, e.g., projections, rings,ridges, ribs, embossments, depressions, grooves, and/or other grippingstructures. The three-dimensional surface elements can be provided inany suitable manner, such as, e.g., by the addition of material, and/orby impressing, such as, e.g., by embossing, or compressing the surfaces.For example, the indentation region can include one or more flattenedsides and/or one or more spaces for a decorative marking or a character,such as, e.g., an embossed and/or printed marking or character. Inaddition, or alternatively, the surfaces of the indentation region caninclude a material that can provide a frictional resistance for theuser's fingers during the insertion of the applicator into the body.Suitable materials that can provide friction include, for example,abrasive materials, high wet coefficient of friction materials, pressuresensitive adhesives, or any combinations thereof.

The pessary device can be used daily. For example, in certainembodiments, a user can insert the pessary device, wear the pessarydevice for a suitable wear time, such as, for example, up to 4 hours, upto 5 hours, up to 6 hours, up to 7 hours, up to 8 hours, up to 9 hours,up to 10 hours, up to 11 hours, or up to 12 hours, or more, remove thepessary device, dispose of the pessary device, and insert a new pessarydevice.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

All documents cited in the Detailed Description of the Invention are, inrelevant part, incorporated herein by reference; the citation of anydocument is not to be construed as an admission that it is prior artwith respect to the present invention. To the extent that any meaning ordefinition of a term in this document conflicts with any meaning ordefinition of the same term in a document incorporated by reference, themeaning or definition assigned to that term in this document shallgovern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. A pessary product, comprising: a. An applicator comprising a barrel region and a grip region; and b. A pessary device disposed within the barrel region, the pessary device comprising a top, a base, and a length; c. Wherein the pessary device does not change in size and diameter during the entire usage experience, including prior to insertion, during use, and upon removal.
 2. The pessary product of claim 1, wherein the pessary device base includes a pressure region.
 3. The pessary product of claim 1, wherein the pessary device top includes a pressure region.
 4. The pessary product of claim 2, wherein the pressure region is convex.
 5. The pessary product of claim 1, wherein the pessary device includes a flexile region apart from the pressure region and the pressure region is more resistant than the flexile region.
 6. The pessary product of claim 1, wherein the pessary device is in the shape of a teardrop, an hourglass, a waisted cylinder, a figure-8, a peanut, a heart, or a vase.
 7. The pessary product of claim 1, wherein the pessary device length is less than 60 mm.
 8. The pessary product of claim 1, wherein the pessary device is a unitary construction.
 9. The pessary product of claim 1, wherein the grip region comprises a grip element selected from the group comprising projections, rings, ridges, ribs, embossments, depressions, grooves, and/or other gripping structures.
 10. A pessary product, comprising: a. an applicator made from an injection or blow moldable material; and b. a pessary device disposed within the barrel region, the pessary device at least partially made from an injection or blow moldable material.
 11. The pessary product of claim 10, wherein pessary device has a top, a base, and a length.
 12. The pessary product of claim 10, wherein the pessary device base includes a pressure region.
 13. The pessary product of claim 10, wherein the pessary device top includes a pressure region.
 14. The pessary product of claim 12, wherein the pressure region is convex.
 15. The pessary product of claim 11, wherein the pessary device further includes a flexile region comprising a minimum diameter, the flexile region being disposed between the top and the base.
 16. The pessary product of claim 10, wherein the pessary device is in the shape of a teardrop, an hourglass, a waisted cylinder, a figure-8, a peanut, a heart, or a vase.
 17. The pessary product of claim 10, wherein the pessary device length is less than 60 mm.
 18. The pessary product of claim 10, wherein the pessary device is a unitary construction.
 19. The pessary product of claim 10, wherein the applicator comprises at least one grip element.
 20. The pessary product of claim 19, wherein the at least one grip element is a three-dimensional surface element selected from the group comprising projections, rings, ridges, ribs, embossments, depressions, grooves, and/or other gripping structures. 